FDA Drug recall D-1394-2016

2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Ca…

FDA Drug
Class II
terminated
Published 2016-07-27

On 2016-07-27 the FDA classified a Class II recall of 2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Ca… by Pharmedium Services, citing presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1394-2016
Classification	Class II
Status	terminated
Initiated	2016-05-05
Published	2016-07-27
Last updated	2026-09-13 11:51 UTC
Company	Pharmedium Services
Distribution	US

Product

2 mcg/mL Fentanyl Citrate and 0.083% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2K8871(NDC 61553-871-48), 250 mL in 250 mL Yellow Smiths Medical Cassette, Service Code 2T8871 (NDC 61553-871-50), Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141

Reason

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

Identifiers

code_info	Service Code 2K8176 , Lot Number 160460099M , Exp. Date 5/10/2016 ; Service Code 2K8176 , Lot Number 160480269M , Exp.… Service Code 2K8176 , Lot Number 160460099M , Exp. Date 5/10/2016 ; Service Code 2K8176 , Lot Number 160480269M , Exp. Date 5/12/2016 ; Service Code 2K8176 , Lot Number 160560160M , Exp. Date 5/20/2016 ; Service Code 2K8176 , Lot Number 160630171M , Exp. Date 5/27/2016 ; Service Code 2K8176 , Lot Number 160690141M , Exp. Date 6/2/2016 ; Service Code 2K8176 , Lot Number 160740128M , Exp. Date 6/7/2016 ; Service Code 2K8176 , Lot Number 160750247M , Exp. Date 6/8/2016 ; Service Code 2K8176 , Lot Number 160810137M , Exp. Date 6/14/2016 ; Service Code 2K8176 , Lot Number 160870187M , Exp. Date 6/20/2016 ; Service Code 2K8176 , Lot Number 160940253M , Exp. Date 6/27/2016 ; Service Code 2K8176 , Lot Number 161080131M , Exp. Date 7/11/2016 ; Service Code 2K8871 , Lot Number 160480223M , Exp. Date 5/8/2016 ; Service Code 2K8871 , Lot Number 160670054C , Exp. Date 5/28/2016 ; Service Code 2K8871 , Lot Number 160870033C , Exp. Date 6/17/2016 ; Service Code 2K8967 , Lot Number 16092

code_info

Service Code 2K8176 , Lot Number 160460099M , Exp. Date 5/10/2016 ; Service Code 2K8176 , Lot Number 160480269M , Exp.…

Service Code 2K8176 , Lot Number 160460099M , Exp. Date 5/10/2016 ; Service Code 2K8176 , Lot Number 160480269M , Exp. Date 5/12/2016 ; Service Code 2K8176 , Lot Number 160560160M , Exp. Date 5/20/2016 ; Service Code 2K8176 , Lot Number 160630171M , Exp. Date 5/27/2016 ; Service Code 2K8176 , Lot Number 160690141M , Exp. Date 6/2/2016 ; Service Code 2K8176 , Lot Number 160740128M , Exp. Date 6/7/2016 ; Service Code 2K8176 , Lot Number 160750247M , Exp. Date 6/8/2016 ; Service Code 2K8176 , Lot Number 160810137M , Exp. Date 6/14/2016 ; Service Code 2K8176 , Lot Number 160870187M , Exp. Date 6/20/2016 ; Service Code 2K8176 , Lot Number 160940253M , Exp. Date 6/27/2016 ; Service Code 2K8176 , Lot Number 161080131M , Exp. Date 7/11/2016 ; Service Code 2K8871 , Lot Number 160480223M , Exp. Date 5/8/2016 ; Service Code 2K8871 , Lot Number 160670054C , Exp. Date 5/28/2016 ; Service Code 2K8871 , Lot Number 160870033C , Exp. Date 6/17/2016 ; Service Code 2K8967 , Lot Number 16092

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1394-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.